OsteoporosisNCT00730184
Does Potassium Bicarbonate Improve the Effect of Dietary Protein on Bone and Muscle?
A study testing potassium bicarbonate in people with Osteoporosis and Sarcopenia, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this study is to examine whether adding the basic salt potassium bicarbonate to the diet will have a positive effect on how dietary protein affects your bone and muscle. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia
- What is being tested?
- potassium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This study will be conducted in subjects with body mass index < 38 kg/m2.
- Women must be at least 6 months since last menses.
- Subjects must be willing to maintain their usual exercise level and agree not to attempt to gain or lose weight or change their diets substantially during the study.
- Subjects will not be allowed to take their own calcium or vitamin D supplements from one week before their screening visit through the end of the study.
- They must also agree not to ingest bicarbonate- or potassium-rich products such as selected antacids and salt substitutes during the study.
- They must also agree not to consume alcohol during the study.
Who cannot join
- Medications
- Oral glucocorticoid use for > 10 days in the last 3 months
- Estrogen, raloxifene, or calcitonin use in the last 6 months, bisphosphonate or teriparatide use in the last 2 years
- Current use of diuretics
- Regular use of NSAIDS (> 3 times per wk) or anabolic drugs (steroids or other). Note that subjects may use acetominophen for joint or other discomforts during the study.
- Conditions/Diseases
Show all 25Show fewer
- Renal disease including kidney stones in the past 5 years or creatinine clearance < 50 ml/min/1.73 X m2 of body surface area
- Cirrhosis
- GERD requiring treatment with alkali-containing antacids (use of Lowsium okay)
- Hyperparathyroidism
- Untreated thyroid disease
- Significant immune disorder such as rheumatoid arthritis, SLE
- Current unstable heart disease
- Active malignancy or cancer therapy in the last year
- 24-hr urine calcium > 300 mg/d after 1 wk off of calcium supplements
- Subjects with arrythmias (surgically treated arrythmias acceptable), or myocardial infarction in last 12 months
- Total hip T score of < -3.0
- Abnormal serum calcium; alkaline phosphatase >10% above the upper end of the reference range
- Adrenal insufficiency, primary aldosteronism, Bartter's syndrome
- Diabetes mellitus (fasting blood sugar > 130)
- Alcohol use exceeding 2 drinks/day
- Peptic ulcers or esophageal stricture
- Screening serum 25(OH)D levels below 16 ng/ml
- Vegetarians
- Other abnormalities in screening labs, at discretion of the study physician (principal investigator)
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
The purpose of this study is to examine whether adding the basic salt potassium bicarbonate to the diet will have a positive effect on how dietary protein affects your bone and muscle.
Read the detailed description
The balance between the amount of protein in the diet (anabolic component) and the net acid load of the diet (catabolic component) in part determines whether the diet as a whole has a net anabolic or catabolic effect on bone and muscle. This study will investigate whether the addition of an alkaline salt of potassium, potassium bicarbonate, will allow dietary protein to have a more favorable net impact on intermediary indices of bone and muscle conservation than is observed with protein in the usual acidic environment.
Men and postmenopausal women, age 50 and older, will be enrolled in this 42-day study in order to have 20 completers. Subjects may continue in the study for up to an additional two weeks should this be necessary for reasons related to intercurrent illness (unrelated to the research) or scheduling circumstances. Over the first 15 days, subjects will be placed on gradually increasing doses, up to a maximum of 90 mmol/d of potassium bicarbonate or placebo. They will remain on this dose for the rest of the study. Subjects will then have two 10-day metabolic diet cycles each, in random order, as follows:
Group 1 - low protein diet (0.5 g/kg/d) then high protein diet (1.5 g/kg/d) Group 2 - high protein diet (1.5 g/kg/d) then low protein diet (0.5 g/kg/d)
There will be a 5-day period between the two metabolic diets in which subjects consume their usual diets but continue to take the study pills.
- Conditions
- Osteoporosis, Sarcopenia
- Being tested
- potassium bicarbonate, Placebo (microcrystalline cellulose)
- Keywords
- acid-base, potassium, acidosis, osteoporosis, sarcopenia, calcium absorption, dietary protein
- Medical subject headings
- Osteoporosis, Sarcopenia, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
potassium bicarbonateDietary supplement
90 mmol/d given as 4 tablets after each meal, with a full glass of water
Placebo (microcrystalline cellulose)Dietary supplement
Given as 4 tablets after each meal, with a full glass of water
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants receive potassium bicarbonate in dosage of 90 mmol/d. This compound has no other name. Receives: Dietary Supplement: potassium bicarbonate |
| 2 | Placebo comparator | Participants receive placebo as microcrystalline cellulose. This compound has no other name. Receives: Dietary Supplement: Placebo (microcrystalline cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the impact of administration of an alkalinizing salt on urinary nitrogen excretion in older men and women.
Measured: before and after low and high protein diet cycles
To determine the impact of administration of an alkalinizing salt on urinary calcium excretion in the same population.
Measured: before and after low and high protein diet cycle
Secondary outcomes (3)
To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on biochemical markers of bone turnover in the same population.
Measured: before and after low and high protein diet cycles
To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on calcium absorption in the same population.
Measured: before and after low and high protein diet cycles
To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on serum IGF-1 in the same population.
Measured: before and after low and high protein diet cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Investigators
- Bess Dawson-Hughes, MD, Principal investigator, Tufts UniversityLisa Ceglia, MD, Study director, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730184
- Sponsor's protocol ID
- 2510
- Other IDs
- 7937
- Status last verified
- Aug 2008
- First submitted
- 5 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ceglia L, Abrams SA, Harris SS, Rasmussen HM, Dallal GE, Dawson-Hughes B. A simple single serum method to measure fractional calcium absorption using dual stable isotopes. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):653-6. doi: 10.1055/s-0029-1234088. Epub 2009 Oct 23.
PubMed 19856249
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Potassium Bicarbonate Improve the Effect of Dietary Protein on Bone and Muscle?
- ClinicalTrials.gov ID
- NCT00730184
- Acronym / sponsor ID
- 2510
- Conditions
- Osteoporosis, Sarcopenia
- Keywords
- acid-base, potassium, acidosis, osteoporosis, sarcopenia, calcium absorption, dietary protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether adding the basic salt potassium bicarbonate to the diet will have a positive effect on how dietary protein affects your bone and muscle.
Detailed description
The balance between the amount of protein in the diet (anabolic component) and the net acid load of the diet (catabolic component) in part determines whether the diet as a whole has a net anabolic or catabolic effect on bone and muscle. This study will investigate whether the addition of an alkaline salt of potassium, potassium bicarbonate, will allow dietary protein to have a more favorable net impact on intermediary indices of bone and muscle conservation than is observed with protein in the usual acidic environment.
Men and postmenopausal women, age 50 and older, will be enrolled in this 42-day study in order to have 20 completers. Subjects may continue in the study for up to an additional two weeks should this be necessary for reasons related to intercurrent illness (unrelated to the research) or scheduling circumstances. Over the first 15 days, subjects will be placed on gradually increasing doses, up to a maximum of 90 mmol/d of potassium bicarbonate or placebo. They will remain on this dose for the rest of the study. Subjects will then have two 10-day metabolic diet cycles each, in random order, as follows:
Group 1 - low protein diet (0.5 g/kg/d) then high protein diet (1.5 g/kg/d) Group 2 - high protein diet (1.5 g/kg/d) then low protein diet (0.5 g/kg/d)
There will be a 5-day period between the two metabolic diets in which subjects consume their usual diets but continue to take the study pills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: potassium bicarbonateParticipants receive potassium bicarbonate in dosage of 90 mmol/d. This compound has no other name. |
| 2 | Placebo comparator | Dietary Supplement: Placebo (microcrystalline cellulose)Participants receive placebo as microcrystalline cellulose. This compound has no other name. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- This study will be conducted in subjects with body mass index < 38 kg/m2.
- Women must be at least 6 months since last menses.
- Subjects must be willing to maintain their usual exercise level and agree not to attempt to gain or lose weight or change their diets substantially during the study.
- Subjects will not be allowed to take their own calcium or vitamin D supplements from one week before their screening visit through the end of the study.
- They must also agree not to ingest bicarbonate- or potassium-rich products such as selected antacids and salt substitutes during the study.
Key exclusion criteria (25 listed)
- Medications
- Oral glucocorticoid use for > 10 days in the last 3 months
- Estrogen, raloxifene, or calcitonin use in the last 6 months, bisphosphonate or teriparatide use in the last 2 years
- Current use of diuretics
- Regular use of NSAIDS (> 3 times per wk) or anabolic drugs (steroids or other). Note that subjects may use acetominophen for joint or other discomforts during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| potassium bicarbonate90 mmol/d given as 4 tablets after each meal, with a full glass of water | Dietary supplement | 1 |
| Placebo (microcrystalline cellulose)Given as 4 tablets after each meal, with a full glass of water | Dietary supplement | 2 |
Primary outcome
To determine the impact of administration of an alkalinizing salt on urinary nitrogen excretion in older men and women.
Time frame: before and after low and high protein diet cycles
To determine the impact of administration of an alkalinizing salt on urinary calcium excretion in the same population.
Time frame: before and after low and high protein diet cycle
3 secondary outcomes
To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on biochemical markers of bone turnover in the same population.
Time frame: before and after low and high protein diet cycles
To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on calcium absorption in the same population.
Time frame: before and after low and high protein diet cycles
To determine whether the administration of an alkalinizing salt of potassium alters the effect of protein on serum IGF-1 in the same population.
Time frame: before and after low and high protein diet cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
- Derived from this study: PubMed 19856249Ceglia L, Abrams SA, Harris SS, Rasmussen HM, Dallal GE, Dawson-Hughes B. A simple single serum method to measure fractional calcium absorption using dual stable isotopes. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):653-6. doi: 10.1055/s-0029-1234088. Epub 2009 Oct 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bess Dawson-Hughes, MD principal investigator
Tufts University
Lisa Ceglia, MD study director
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing potassium bicarbonate in people with Osteoporosis and Sarcopenia, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the impact of administration of an alkalinizing salt on urinary nitrogen excretion in older men and women. (time frame: before and after low and high protein diet cycles). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00730184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2008.